[Translation] A multicenter, open-label, non-randomized phase I/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics, radiation dosimetry, and preliminary efficacy of INR102 injection in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)
I期:评价INR102在PSMA阳性mCRPC受试者中的安全性和耐受性;确定INR102单次给药的剂量限制性毒性(DLT)(如有)、最大耐受剂量(MTD)(如有),以及Ⅱa期研究推荐剂量(RP2D)。Ⅱa期:评价INR102在PSMA阳性mCRPC受试者中的初步抗肿瘤活性。
[Translation] Phase I: Evaluate the safety and tolerability of INR102 in PSMA-positive mCRPC subjects; determine the dose-limiting toxicity (DLT) (if any), maximum tolerated dose (MTD) (if any) of a single dose of INR102, and the recommended dose (RP2D) for Phase IIa studies. Phase IIa: Evaluate the preliminary anti-tumor activity of INR102 in PSMA-positive mCRPC subjects.